SUPPLY CHAIN ARTICLES
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![Engraver-wood-working-GettyImages-505274864]( "Defining The RNA Therapeutics Industry In 2023")
Defining The RNA Therapeutics Industry In 2023Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.
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![New Years Resolutions-GettyImages-1289531659]( "ARW's ATMP Manufacturing Must-Reads (2024 NEW YEAR'S RESOLUTIONS EDITION!)")
ARW's ATMP Manufacturing Must-Reads (2024 NEW YEAR'S RESOLUTIONS EDITION!)Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email.
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![Business Unity-GettyImages-1253212054]( "The RNA Therapeutics Supply Chain: A Platform of Relationships")
The RNA Therapeutics Supply Chain: A Platform of RelationshipsConversations digging into RNA-specific sourcing considerations have been few and far between. Enter Sanofi's Greg Troiano. Together, we delved into the nuances, challenges, and opportunities for growth that currently exist within the mRNA drug substance and drug product (i.e., mRNA-LNP) raw material sourcing worlds.
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![Talimogene laherparepvec vaccine-GettyImages-960686030]( "Addressing Challenges In Serialization For Complex Therapeutics")
Addressing Challenges In Serialization For Complex TherapeuticsThe magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.
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![iStock-997784670-selection-chain]( "Biomanufacturing Capacity Crunch: It's The Supply Chain's Fault")
Biomanufacturing Capacity Crunch: It's The Supply Chain's FaultWhat's behind the protracted biopharma manufacturing capacity crunch, when will it end, and what are manufacturers doing to keep supply on track? During Biotech Week in Boston ad BioProcess International, CDMOs and sponsors weighed in.
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![GettyImages-1269045566-rna]( "The Expanding Patent Landscape For RNA-Based Therapeutics")
The Expanding Patent Landscape For RNA-Based TherapeuticsThe COVID-19 pandemic thrust RNA-based therapeutics into the spotlight. Before that, only a handful had received regulatory approval. Why are RNA-based therapeutics seeing more patent activity now and how should biotech companies mitigate patent risks? Attorneys from Neal Gerber Eisenberg share their insights.
SUPPLY CHAIN VIDEOS
Sanofi’s Sumit Luthra shares several of the analytical and manufacturing innovations/improvements he’s watching and waiting for that will improve our knowledge of LNP composition, structure, function, and quality.
We all know that plasmid quality is foundational in dictating the quality of the final mRNA drug substance. In this clip homing in on upstream process considerations, speakers Stu Sundseth (Tune Therapeutics), Marc Wolfgang (Sail Biomedicines), and Christian Dohmen (Ethris) outline some of the most important CQAs for plasmids and the impact they can have on the resulting quality of the mRNA drug substance for linear mRNA.
Advancing RNA Live panelists Tyler Goodwin and April Sena start off our latest discussion on technology innovations in mRNA production by surveying the current manufacturing process for plasmid production, highlighting where they’ve seen advancements and what biotechs need to consider to obtain plasmids of the appropriate quality for mRNA production.
Here, Advancing RNA Live speakers Khaled Yamout, Sanofi’s Francoise Ribes, and Camp4’s Satya Kuchimanchi share which supply chain advancements they would like to see in the near future, as well as how they anticipate these changes & evolutions could impact each modality’s growth.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1387090964 cell and gene therapy]( "Gene And Cell Therapy: Planning For Manufacturing Success Early")
As gene therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations, explore how to optimize plasmid production and reach patients with efficiency.
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![GettyImages-624034258 chemical mixing]( "Demystifying CRISPR gRNA Chemical Modifications")
Chemical modifications on CRISPR gRNAs enhance stability, editing efficiency, and reduce immune responses, enabling in vivo applications and clinical success.
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![iStock-1293772874-lab-plasmid-gene therapy-DNA]( "Novel Lipid Nanoparticle Delivery Reagent And Manufacturing Workflow")
We aim to highlight that commercially available LNP reagent mix, GenVoy-ILM, is an accessible and easy-to-use LNP formulation that allows for rapid preclinical development of RNA vaccines.
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![mRNA GettyImages-1428646288]( "mRNA Synthesis Reagents And Manufacturing")
As novel mRNA therapies are starting to enter clinical stages of development, Aldevron is providing critical support in a number of ways with specialized products and services.
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![iStock-1087219198-lab-computer-cleanroom-research-development-production]( "GMP-Source® And Phase-Appropriate Use For Early-Stage Clinical Trials")
GMP-Source is a more robust, less rigid alternative to full cGMP production that mirrors nearly all of the oversight and quality standards of full cGMP production while relaxing certain commercial standards, helping companies overcome the hurdles that can stall early development.
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![test tubes, dropper, glass vials, pharmaceutical innovation-GettyImages-2157720330]( "Move Beyond LAL")
Uncover how how switching from LAL to rFC can enhance sustainability, improve testing reliability, and strengthen supply-chain resilience in endotoxin testing.
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![GettyImages-1284041821 asian vaccine]( "Revolutionizing Patient-Centric Supply Chains To Improve Vaccine Access")
Transparent collaboration and innovation are essential to establishing an infrastructure that supports more agile business models and empowers widespread vaccine access.
